PAR-26-115-Full-Announcement.html

Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Funding Opportunity Title

Institutional Network Award for Promoting Kidney, Urologic, and Hematologic Research Training (U2C - Clinical Trial Not Allowed)

Activity Code

U2C Resource-Related Research Multi-Component Projects and Centers Cooperative Agreements

Announcement Type

Reissue of

PAR-23-248

Related Notices

Check for any recent Notices of NIH Policy Changes that may impact application requirements.

Funding Opportunity Number (FON)

PAR-26-115

Companion Notice of Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)

93.847

Notice of Funding Opportunity Purpose

Responding to the needs of the scientific community to bolster a vibrant and sustainable research workforce, the Division of Kidney, Urologic, and Hematologic Diseases (KUH) at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has incorporated additional flexibilities for institutional training programs serving the mission interests of non-malignant kidney, urologic, and hematologic diseases, encompassing both adult and pediatric conditions. The purpose of this notice of funding opportunity is to invite applications for Institutional Network Awards (U2C-TL1) to recruit, train, and retain the next generation of researchers and provide them with the coordinated support, resources, and networks they need to succeed and lead. To maximize integration and promote a highly connected trainee community, institutions are invited to submit a single, unified U2C-TL1 application. Representation across all kidney, urologic, and hematologic disciplines is not expected or required. If feasible, applications may include multiple departments within and across institutions. It is expected that each U2C-TL1 award will actively participate in the Kidney, Urology and Hematology Research-Training Network (KUHR-TN), a nationwide coalition of individual U2C-TL1 awards.

Funding Opportunity Goal(s)

To promote extramural basic and clinical biomedical research that improves the understanding of the mechanisms underlying disease and leads to improved preventions, diagnosis, and treatment of diabetes, digestive, and kidney diseases. Programmatic areas within the National Institute of Diabetes and Digestive and Kidney Diseases include diabetes, digestive, endocrine, hematologic, liver, metabolic, nephrologic, nutrition, obesity, and urologic diseases.

Key Dates

Posted Date

Open Date (Earliest Submission Date)

April 25, 2026

The following table includes NIH standard due dates marked with an asterisk.

May 25, 2026 *

May 25, 2026 *

Not Applicable

April 2027

May 25, 2027 *

May 25, 2027 *

Not Applicable

April 2028

May 25, 2028 *

May 25, 2028 *

Not Applicable

April 2029

All applications are due by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Expiration Date

May 26, 2028

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information Key Dates Part 2. Full Text of Announcement Section I. Notice of Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Background The Kidney, Urologic, and Hematologic research communities are facing daunting workforce issues. As such, there is a critical need to recruit, train, and retain trainees engaged in research in KUH mission areas, including non-malignant kidney, urologic, and/or hematologic research, encompassing both adult and pediatric conditions, and provide them with the coordinated support, resources, and networks they need to succeed and lead.

Solutions to the difficult and complicated scientific questions facing the kidney, urologic, and hematologic communities demand well-trained basic, translational, and clinical researchers who can employ their skills in a team-based setting and apply rigorous experimental approaches utilizing novel techniques. To develop and grow this workforce, effective training programs must encompass critical thinking, scientific literacy, problem-solving, communication, collaboration, teamwork, adaptability, resilience, and mentoring.

Purpose The purpose of this Notice of Funding Opportunity (NOFO) is to cultivate a highly integrated cohort of people and resources to propel training in KUH mission areas through Institutional Network Awards (U2C-TL1).

When feasible, each Institutional Network Award (U2C-TL1) is encouraged to leverage all available resources and partner institutions to maximize recruitment, training, and retention by:

The U2C cooperative component will provide administrative, networking, professional development, and resources for the Institutional Network Award activities, while the TL1 training component (equivalent to a T32) will allow the institution(s) to recruit and fund at least five (5) highly competitive pre- and/or post-doctoral trainees engaged in KUH research. Each U2C-TL1 Award is expected to have a:

Additional Information:

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

Funding Instrument

Cooperative Agreement: A financial assistance mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this NOFO.

Application Types Allowed

New

Renewal

Resubmission

The OER Glossary and the How to Apply - Application Guide provides details on these application types. Only those application types listed here are allowed for this NOFO.

Clinical Trial?

Not Allowed: Only accepting applications that do not propose clinical trials.

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

The total costs of the U2C (Administrative Core plus Networking and Professional Development Core) should not exceed 40% of the total cost of the TL1 (NRSA Training Core). In other words, the total costs of the U2C divided by the total costs of the TL1 should not exceed 0.40.

Award Project Period

The scope of the proposed project should determine the project period. The maximum project period is 5 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Local Governments

Federal Governments

Eligible Agencies of the Federal Government

U.S. Territory or Possession

Other

Independent School Districts

Public Housing Authorities/Indian Housing Authorities

Native American Tribal Organizations (other than Federally recognized tribal governments)

Faith-based or Community-based Organizations

Regional Organizations

Foreign Organizations/International Collaborations

Non-domestic (non-U.S.) Entities (Foreign Organization) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

NIH will no longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts. All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. This new requirement was effective, May 1, 2025.

Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding. This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components, funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.

Required Registrations

Applicant organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply- Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.

System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.

NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.

Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.

eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.

Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply - Application Guide.

The PD(s)/PI(s) should be an active investigator in a scientific area relevant to the mission of KUH and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD(s)/PI(s) will be responsible for the selection and appointment of trainees to the approved research training program, and for the overall direction, management, administration, and evaluation of the program. The PD(s)/PI(s) will be expected to monitor and assess the program and submit all documents and reports as required.

Multiple PD(s)/PI(s) are allowed, particularly when each brings a unique perspective and skill set that will enhance the training program. At least one of the multiple PD(s)/PI(s) should be an investigator with an active research program in basic, translational, or clinical science aligned with the mission of KUH, capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. Additional PD(s)/PI(s), including individuals with experience in areas such as science education, program evaluation, mentoring, and career development and advancement for early-career scientists, may be included to achieve the overall goal to recruit, train, and retain trainees engaged in KUH research and provide them with the coordinated support, resources, and networks they need to succeed and lead.

2. Cost Sharing This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2- Definitions of Terms.

3. Additional Information on Eligibility Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.

A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Additional Information on Eligibility for the Training Core (TL1)

Preceptors/Mentors Program faculty should be active researchers in the biomedical sciences as demonstrated by recent publications and research support in the area of the proposed research training program. Programs are encouraged to recruit prospective preceptors/mentors from faculty at different career stages (for example, early stage investigators as well as senior faculty). All program faculty should have a mentoring philosophy appropriately tailored to the needs of potential trainees that ensures trainees will receive the tailored mentorship needed to develop skills and advance their career. Program faculty should also have sufficient time to commit to training given their other professional obligations.

Trainees The applicant organization will select the trainees to be supported by the research training program and is responsible for establishing trainee eligibility and selection criteria that are consistent with applicable law. The individual to be trained must be a citizen or a noncitizen national of the United States or have been lawfully admitted for permanent residence at the time of appointment. Additional details on citizenship, training period, and aggregate duration of support are available in the NIH Grants Policy Statement. All trainees are required to pursue their research training full time, normally defined as 40 hours per week, or as specified by the sponsoring institution in accordance with its own policies. Appointments are normally made in 12-month increments, and no trainee may be appointed for less than 9 months during the initial period of appointment, except with prior approval of the awarding unit.

Predoctoral trainees: Predoctoral trainees must be enrolled in a program leading to a PhD or in an equivalent research doctoral degree program. Health-professional students who wish to interrupt their studies for a year or more to engage in full-time research training before completing their formal training programs, are also eligible.

Postdoctoral trainees: Postdoctoral trainees must have received, as of the beginning date of the NRSA appointment, a Ph.D., M.D., D.D.S., or comparable doctoral degree from an accredited domestic or foreign institution. Comparable doctoral degrees include, but are not limited to, the following: D.M.D., DC, DO, DVM., OD, DPM, ScD, EngD, DrPH, DNSc, DPT, PharmD, ND (Doctor of Naturopathy), DSW, PsyD, as well as a doctoral degree in nursing research. Documentation by an authorized official of the degree-granting institution certifying all degree requirements have been met prior to the beginning date of the training appointment is acceptable. Individuals in postgraduate clinical training, who wish to interrupt their studies for a year or more to engage in full-time research training before completing their formal training programs, are also eligible.

Additional information:

Section IV. Application and Submission Information

1. Requesting an Application Package The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this NOFO. See the administrative office for instructions if planning to use an institutional system-to-system solution.

2. Content and Form of Application Submission It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed in this notice of funding opportunity to do otherwise (in this NOFO, in a policy notice, or other notice from NIH Guide for Grants and Contracts) and where instructions in the How to Apply - Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Page Limitations All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed.

Required

Required

Required

Required

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in How to Apply- Application Guide and should be used for preparing a multi-component application.

Overall Component When preparing the application, use Component Type ‘Overall’.

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions, as noted.

SF424(R&R) Cover (Overall) Complete entire form.

PHS 398 Cover Page Supplement (Overall) Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Research & Related Other Project Information (Overall) Follow standard instructions.

Project/Performance Site Locations (Overall) Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research and Related Senior/Key Person Profile (Overall) Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this NOFO) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Overall) The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Overall) Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component.

Specific Aims: Describe the specific aims of the program as an institutional resource to recruit, train, and retain the next generation of researchers and provide them with the coordinated support, resources, and networks they need to succeed and lead.

Research Strategy: This section should address the overall vision and mission of the program, the institutional commitment and accomplishments of supporting innovative training, and the institutional approach to fostering a trainee cohort across multiple career stages.

Vision and Mission:

Institutional Track Record of Innovative Training:

Describe the institution’s commitment and accomplishments over the last five years in promoting innovative training. Highlight the accomplishments of recent trainees that have benefited from such training. Describe institutional programs and incentives for promoting trainee networking and professional development across the participating departments, if applicable.

Letters of Support: Letters of Support should describe the institutional support for the program and commitment to supporting the goals of the Institutional Network Award. Letters should be submitted from the chairs of all participating departments committing to sharing of resources and facilities to provide supported trainees an exceptional training experience.

Resource Sharing Plan:

Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide.

Other Plan(s):

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions:

A Data Management and Sharing Plan is not applicable for this NOFO.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in How to Apply- Application Guide; any instructions provided here are in addition to the How to Apply - Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall) When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the How to Apply - Application Guide must be followed.

Not applicable. Do not complete.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed.

Not applicable. Do not complete.

PHS Assignment Request Form (Overall) All instructions in the How to Apply- Application Guide must be followed.

Administrative Core When preparing your application, use Component Type ‘Admin Core.’

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Administrative Core) Complete only the following fields:

PHS 398 Cover Page Supplement (Administrative Core) Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core) Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Administrative Core) List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Administrative Core)

Budget (Administrative Core) Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Administrative Core) Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims: The specific aims should reflect the integrated approach to establish governance, manage resources, and ensure program goals are met.

Research Strategy:

The application should describe:

Letters of Support: All Letters of Support should be included in the Overall component.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide, with the following modification:

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Data Management and Sharing Plan is not applicable for this NOFO.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Administrative Core) When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the How to Apply- Application Guide must be followed.

Delayed Onset Study Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed.

Networking and Professional Development Core When preparing your application, use Component Type ‘Core.’

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Networking and Professional Development Core) Complete only the following fields:

PHS 398 Cover Page Supplement (Networking and Professional Development Core) Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Networking and Professional Development Core) Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Networking and Professional Development Core) List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Networking and Professional Development Core)

Budget (Networking and Professional Development Core) Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Networking and Professional Development Core) Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims: Describe the aims of the Networking and Professional Development Core towards fostering local peer- and near-peer networking, developing tailored and structured educational experiences to prepare trainees for the next step in their scientific careers and providing a robust mentoring environment. Activities supported by the Networking and Professional Development Core are expected to be site- and context-specific and address trainee needs, and programmatic goals best accomplished locally.

Research Strategy:

The application should describe:

Local trainee peer network

Trainee professional development (while some examples are listed below, it is not expected that all of these examples will be incorporated; applicants should propose strategies commensurate with the proposed budget)

Preceptor/Mentor professional development (while some examples are listed below, it is not expected that all of these examples will be incorporated; applicants should propose strategies commensurate with the proposed budget)

In addition to the local activities, national networking and professional development resources will be available through the KUH-FAMILY Coordinating Center, once launched, to all TL1-appointed trainees and their mentors. It is expected that the local resources will serve as the foundation for achieving the main goal of the KUH-FAMILY Coordinating Center to create and sustain an active, national, peer-to-peer network and community of individuals engaged in research in KUH mission areas across career stages.

Letters of Support: All Letters of Support should be included in the Overall component.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide, with the following modification:

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Data Management and Sharing Plan is not applicable for this NOFO.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Networking and Professional Development Core) When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the How to Apply- Application Guide must be followed.

Delayed Onset Study Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed.

Training Core When preparing your application, use Component Type ‘NSRA Training.’

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Training Core) Complete only the following fields:

PHS 398 Cover Page Supplement (Training Core) Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Training Core) Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Training Core) List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Training Core)

Budget (Training Core) Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Training Core) Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

The PHS 398 Research Training Program Plan Form is comprised of the following sections:

Follow all instructions provided in the How to Apply - Application Guide:

Particular attention must be given to the required Training Data Tables. Applicants should summarize, in the body of the application, key data from the tables that highlight the characteristics of the prospective candidate pool, faculty mentors, the educational and career outcomes of past participants, and other factors that contribute to the overall environment of the program.

For New Predoctoral Training, submit tables: 1, 2, 3, 4, 5A, 8A.

For New Postdoctoral Training, submit tables: 1, 2, 3, 4, 5B, 8C.

For New Mixed Pre and Postdoctoral Training, submit Tables: 1, 2, 3, 4, 5A, 5B, 8A, 8C.

Training Program In addition to the information specified in the Application Guide, describe the following for each section of the Program Plan attachment:

Background:

Provide a rationale for the proposed program and the choice of career stage of trainees requested. Do not include a lengthy historical background of training at the institution but instead focus on current training challenges and how the institution is best positioned to recruit, train, and retain the next generation of researchers and provide them with the coordinated support, resources, and networks they need to succeed and lead.

Program Plan Program Administration (Training Program Director(s)/Principal Investigator(s)):

The application should describe how the Training Program Director(s)/Principal Investigator(s) (PDs/PIs) will promote the success of the trainees and training program. Multiple PDs/PIs are encouraged, particularly when each brings a unique skill set that will enhance training. The application should expand on the information in the biosketch(es) to address how the PD/PI or PD/PI team has: